Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability, drug levels, and preliminary efficacy of bms-986507 combinations in adult participants with advanced solid tumors

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of bms-986507 combinations in adult participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria * participants must have at least one measurable lesion per response evaluation criteria in solid tumors. * participants must have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * participants must have a life expectancy of at least 3 months at the time of the first dose. exclusion criteria * participants must not have any mixed small cell lung cancer (sclc) and non-small cell lung cancer (nsclc) histology. * participants must not have spinal cord compression, symptomatic central nervous system (cns) metastases. progression of existing cns metastases, or the appearance of new lesions as shown on cns imaging during screening will be excluded. participants with cns metastases discovered during screening may be eligible. * participants must not have a history of serious recurrent infections. * participants must not have a history of severe heart disease. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: non-small cell lung cancer (nsclc) epidermal growth factor receptor mutated (egfrmt) epidermal growth factor receptor wild-type (egfrwt)
effects of glutenshield, a prebiotic, probiotic, and enzyme supplement, on the gut microbiome of adults with gi symptoms

Conditions: Gastrointestinal Symptoms

Summary: this study evaluates the effects of combination probiotic, prebiotic, and enzyme supplementation on the colonic microbiome of individuals with gi symptoms (e.g. diarrhea, constipation, increased gas). half of the participants will receive the placebo while the other half will receive the supplement for 28 days.

the purpose of this research is to identify if there is a relationship between glutenshield, a combination prebiotic, probiotic, and enzyme supplement, and the gut environment. the study will be a split, 28-day randomized, partially blinded design. subjects will be randomly assigned to one of two groups. one group will complete a 28-day treatment period with glutenshield taken 3x/day with meals. the other group will complete a 28-day placebo period with the placebo taken 3x/day with meals. the placebo will contain avicel (cellulose) and bentonite powder (to have a similar color as glutenshield). participants will be blinded to which group/ treatment they are being given. serum and fecal samples will be collected at baseline and on day 29. participants will also complete a gastrointestinal symptoms questionnaire, a food frequency questionnaire and a psychosocial measures of self questionnaire.

Eligibility criteria:
inclusion criteria: * individuals who express gastrointestinal symptoms more than three times per week as identified through the gastrointestinal symptom questionnaire (such as abdominal pain/ discomfort, heartburn, acid regurgitation, bloating, nausea and vomiting, abdominal distention, eructation (burping), increased gas, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation, or feeling of incomplete evacuation) * healthy with few health complications * adults ages 18 or older exclusion criteria: * anyone under the age of 18 * individuals diagnosed with celiacs, ibs, crohn's disease, ulcerative colitis, or short bowel syndrome * individuals who have previously taken glutenshield * individuals who are currently taking prebiotics, probiotics, enzymes, non-steroidal anti-inflammatory drugs, fish oil, and/or fiber supplements (unless use is halted in the voluntary 2-week washout period prior to the study) * individuals who are pregnant or intend to become pregnant during the duration of the study
pelvic floor muscle exercises effect after stoma closure

Conditions: Stoma

Summary: this study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.

sample of study was calculated as 32 using g\*power software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of lin et al. participants were assigned to the experimental and control groups by the stratified block randomization method. the locks were assigned to layers using microsoft excel. the individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the roy adaptation model in addition to routine discharge training. the patients received a pfme training booklet prepared by the researcher. face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. the training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. data was collected a day before discharge, first, second, third, and sixth months after the surgery.

Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 75, * being literate, * having a stoma due to colorectal cancer, * having no previous anal trauma, * having no anal surgery other than colorectal cancer surgery, * having no congenital anorectal anomaly, * having no neurological problem, * having no physical disability, * having no previous experience of pfmes before the surgery, * being cognitively able to answer questions exclusion criteria: * wanting to leave the study, * having had previous biofeedback and electrical stimulation therapy applications, * having another stoma, * not being reachable by phone.

Keywords: stoma stoma and wound care nurse pelvic floor exercises bowel evacuation problems quality of life
treatment of hyperphagia behavioral symptoms in children and adults diagnosed with prader-willi syndrome

Conditions: Hyperphagia in Prader-Willi Syndrome

Summary: the purpose of this study is to evaluate the safety and effectiveness of intranasal fe 992097 in children and adults with prader-willi syndrome.


Eligibility criteria:
inclusion criteria: * male or female 10-18 years of age (both inclusive) * genetically confirmed diagnosis of prader-willi syndrome * determined to be in nutritional phase 3 prader-willi syndrome based on miller et al, 2011 exclusion criteria: * known genetic, hormonal, or chromosomal cause of cognitive impairment other than prader-willi syndrome * presence of currently active psychotic symptoms * presence of any cardiovascular disorders, epilepsy, frequent migraines or severe asthma * previous diagnosis of autism spectrum disorder by a qualified healthcare provider * prior or concomitant use of a selective serotonin reuptake inhibitor (ssri) or selective norepinephrine reuptake inhibitor (snri), antipsychotic medication, wakefulness-promoting drug, or thyroid hormone unless dosage has been stable ≥6 months at time of screening
cpap adherence pilot study among african americans

Conditions: Sleep Apnea

Summary: the goal of the study is to determine the feasibility of a behavioral intervention to improve cpap adherence among african american patients with obstructive sleep apnea.

the investigators propose to pilot test a couple-oriented intervention in a randomized controlled trial of 20 african american patients diagnosed with moderate to severe osa and their partners. half of the patients will receive optimal usual care currently implemented at metrohealth, consisting of sleep therapist-initiated standardized education about osa, sleep hygiene, and cpap use; personalized mask fittings; and follow-up at 1 week to troubleshoot problems with cpap utilization. participants will follow up with their sleep providers per usual. the remaining patients and their bed partners will receive a couple-oriented intervention consisting of guideline-recommended best practices for improving cpap adherence consisting of sleep therapist-initiated standardized education for couples about osa, sleep hygiene, and cpap use; personalized mask fittings; and follow-up at 1 week to troubleshoot problems with cpap utilization. couples will participate in two couple-oriented support groups led by an african american patient with long standing osa treated with cpap and their partner. patients and partners will receive tailored text messages encouraging adherence. in addition, couples will receive five 60-minute virtual cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine that will focus on enhancing couples' knowledge of cpap, patients' self-efficacy to use cpap, couple's relationship dynamics, and partners' skill and self-efficacy in assisting the patient with cpap adherence.

Eligibility criteria:
inclusion criteria: * must have same bed partner(s) for at least 6 months. * must be at least 18 years of age exclusion criteria: * must be proficient in speaking english * non-compliance to management of osa * apnea hypopnea index ≥ 15 events/hours * terminally ill * mentally incompetent * unstable housing * need for bpap or vpap\\pap).

Keywords: obstructive sleep apnea
options spinal cord stimulation programming parameters

Conditions: Pain, Intractable

Summary: the purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. all eligible subjects will undergo a spinal cord stimulation (scs) device trial that includes an intraoperative programming trial. subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. those not reporting a positive response to the programming parameters will be exited from the study. the subjects will complete a number of assessment worksheets to characterize their quality of life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Eligibility criteria:
inclusion criteria: * candidate for spinal cord stimulation (scs) system (trial and implant) per labeled indication(back and leg pain) * willing and able to provide a signed and dated informed consent * at least 18 years old at the time of informed consent * willing and able to attend visits and comply with the study protocol * capable of using the patient programmer and recharging the neurostimulator * willing to not increase pain medications from baseline through the 3-month visit exclusion criteria: * currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results. * psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol. * trialed or implanted with scs, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system * implanted with a cardiac device (e.g., pacemaker, defibrillator)

Keywords: chronic pain intractable pain failed back surgery syndrome
clamp vs off clamp kidney during partial nephrectomy

Conditions: Nephrectomy; Kidney Neoplasm; Glomerular Filtration Rate

Summary: prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.


Eligibility criteria:
inclusion criteria: * normal coagulation trim * pre operative glomerular filtration rate (gfr) \> 60 ml/min * healty contralateral kidney * low (4-6) or intermediate (7-10) renal score * availability of da vinci robotic system exclusion criteria: * altered coagulation trim * pre operative glomerular filtration rate (gfr) \< 60 ml/min * anatomic or functional solitary kidney * renal score \>10

Keywords: renal function off-clamp partial nephrectomy robotic hylar clamping
descriptive pharmacoepidemiological study of patients treated with iressa

Conditions: Lung Cancer

Summary: the aim of the study is to describe the characteristics of patients treated with iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an egfr-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life

descriptive pharmacoepidemiological study of patients treated with iressa

Eligibility criteria:
inclusion criteria: * patients treated with iressa exclusion criteria: * patient included in a therapeutic trial comprising protocol use of iressa * patient included in a therapeutic trial (huriet-serusclat act) * patient refusing to participate in the study

Keywords: lung cancer, france
quality of life after an ambulatory reconstruction of the cruciate ligament

Conditions: Rupture of the Cruciate Ligament

Summary: study to compare the quality of life after reconstruction of the cruciate ligament in hospitalized versus day-clinic patient


Eligibility criteria:
inclusion criteria: * rupture of the cruciate ligament exclusion criteria: -
new periodontal classification

Conditions: Periodontal Diseases; Peri-Implantitis; Gingival Diseases

Summary: a new classification system of periodontal and peri-implant diseases and conditions was proposed by consensus of world experts in 2017. since then there has been ongoing debates among periodontists regarding the application of the new classification. this study aims to shed light on the current understanding of the new classification among egyptian periodontists.

this study was approved by the research ethics committee of faculty of dentistry beni-suef university (id #fdbsurec/27022019/am) and was conducted in full accordance with the world medical association declaration of helsinki 1975, revised in 2003. the questionnaire was anonymous with no personal identification data. completion and submission of the questionnaire was considered an approved informed consent to participate in the study by the research ethic committee. the questionnaire was designed by the authors and pilot tested among a group of 12 periodontists for validation. afterwards, adjustments were made to ensure a clear and comprehensive version of the questionnaire. the questionnaire had a cover letter explaining the nature and purpose of the survey and comprised 15 questions. the first six statements of the questionnaire were descriptive in nature addressing the participant's demographics, and the seventh was a question whether the participant is aware of the new pdl classification or not. only those who were aware of it were asked to proceed to 13 multiple choice questions using likert scale; ranging from strongly disagree to strongly agree or from excellent to poor, in addition to "i don't know" option (8). there were also three open ended questions for further comments at the end of the questionnaire.

Eligibility criteria:
inclusion criteria: * periodontists exclusion criteria: * non periodontists

Keywords: classification periodontal diseases periodontitis peri-implantitis
uterine cavity and blood flow after conservative management of placenta previa/accreta

Conditions: Improving Quality of Life

Summary: bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. about 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of cesarean hysterectomies done for abnormally adherent placentation

no previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate

Eligibility criteria:
inclusion criteria: 1. women age 18-40 years 2. gestational age of pregnancy 28-40 weeks 3. diagnosed antenatally as placenta previa/accreta 4. patients who will be managed by conservative surgical techniques for intraoperative hemorrhage 5. women who will accept to participate in the study and are reliable for follow-up exclusion criteria: * 1- patients who will be managed by hysterectomy 2- patients who will be managed by conservative leaving the placenta in-situ 3- diabetic or hypertensive women 4- women who will refuse to participate in the study
the efficiency of a new sperm-wash device for intrauterine insemination in couples with infertility

Conditions: Infertility; Male Infertility

Summary: this study evaluates the effectiveness of a novel sperm-wash device designed to improve outcomes in intrauterine insemination (iui) for couples with infertility. traditional sperm preparation methods, such as density gradient centrifugation (dgc), are associated with elevated reactive oxygen species (ros) levels and increased sperm dna fragmentation, potentially compromising pregnancy rates. the new device aims to reduce these adverse effects by minimizing oxidative stress and preserving sperm dna integrity. in this prospective, randomized controlled trial, 120 couples will be allocated to either the intervention group using the new device or the control group using dgc. the primary outcome is the clinical pregnancy rate, while secondary outcomes include sperm dna fragmentation. the study hypothesizes that the novel device will result in higher pregnancy rates and reduced dna fragmentation compared to dgc. these findings may support its use as a more physiological approach to sperm preparation in fertility treatment.

this is a prospective, randomized, open-label, parallel-controlled clinical trial conducted at chung shan medical university hospital. the study aims to evaluate the clinical efficacy and safety of a novel sperm-wash device-lenshooke ca0-in couples with infertility undergoing intrauterine insemination (iui). a total of 120 couples will be enrolled and randomly assigned in a 1:1 ratio to the intervention group (lenshooke ca0) or the control group (dgc). sperm quality will be evaluated before and after processing, and iui will be performed following standard clinical procedures. the primary outcome is the clinical pregnancy rate confirmed by ultrasound. the secondary outcome is the sperm dna fragmentation index (dfi), assessed using the sperm chromatin dispersion (scd) test. the study hypothesizes that the novel sperm-wash device will improve pregnancy outcomes and reduce oxidative stress and dna damage compared to the conventional method. the trial aims to provide supporting evidence for a more physiological and efficient sperm selection strategy in assisted reproduction.

Eligibility criteria:
inclusion criteria: * males aged between 25 to 50 years. * part of a couple diagnosed with infertility. * undergoing intrauterine insemination (iui) treatment. * sperm concentration \>15 million/ml, progressive motility \>32%, and total motile sperm count \>40 million after wash. * willingness of both partners to participate and provide informed consent. exclusion criteria: * known female infertility factors requiring assisted reproductive technologies beyond iui. * severe male factor infertility (e.g., oligoasthenoteratozoospermia). * use of donor sperm or oocyte. * chronic illness or medications affecting sperm quality. * prior participation in another clinical trial within the past 3 months.

Keywords: infertility intrauterine insemination (iui) artificial insemination husband sperm selection sperm dna fragmentation oxidative stress fertility treatment male infertility
sequential paclitaxel chemotherapy and radiotherapy as 1st line treatment for elderly esophageal squamous cell cancer

Conditions: Esophageal Squamous Cell Cancer; Elderly Patients

Summary: elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in china. in the investigators phase ii clinical trial proceeded before, the paclitaxel treatment showed good tolerance and efficacy to esophageal squamous cell carcinomas. radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in escc patients. however, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (ctv) are not internationally defined. the investigators then initiated a prospective phase ii clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and safety of the combination.


Eligibility criteria:
inclusion criteria: 1. having signed informed consent age more than 69 years old 2. histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy; 3. no prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months 4. sex is not limited 5. measurable disease according to the recist criteria(diameter of the lesion should be more than 10mm by spiral ct or mri, more than 20mm by common ct, the date of image should be less than 15 days before enrollment) 6. karnofsky performance status ≥80 7. life expectancy of ≥ 3 month 8. wbc \> 3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet \> 100,000/mm3, hb \> 9g/dl(within 14 days before enrollment),alt and ast \< 1.5 times uln (≤5 times uln in patients with liver metastases),bilirubin level \< 1.0 times uln,serum akp \< 2.5 times uln,serum creatinine \< 1.0 times uln 9. no sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃； 10. normal ecg and heart function 11. fertile patients must use effective contraception good compliance exclusion criteria: 1. previous treatment of palliative chemotherapy 2. known hypersensitivity to paclitaxel,cisplatin 3. only with brain or bone metastasis 4. no measurable lesions, eg. pleural fluid and ascites 5. suffer from severe heart disease or disease with other important organs chronic diarrhea or renal dysfunction 6. other previous malignancy within 5 year, except non-melanoma skin cancer 7. mentally abnormal or disable cognition,including cns metastasis